COVID-19 Infection
Conditions
Keywords
Plitidepsin, COVID-19, Post-COVID morbidity
Brief summary
The main objective of this study is to evaluate the incidence of post-COVID morbidity and characterize the complications profile in patients who participated in the APLICOV-PC study. APLICOV-PC study was a multicenter, randomized, proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin (1,5 mg, 2,0 mg and 2,5 mg) administered three consecutive days, in adult patients with confirmed diagnosis of COVID-19 who require hospital admission.
Detailed description
The APLICOV-PC proof of concept study demonstrated the antiviral activity of plitidepsin in terms of reducing viral load, inducing recovery, and impact on lymphocyte reconstitution and other inflammatory parameters. A percentage of patients, which varies between 10 and 25%, continue to show symptoms at 3 months after contracting the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: For some of them this significantly restricts their life, requiring them to take long-term sickness leave from work, and leaving them with sequelae that may continue for more than one year. With this study, Pharmamar intends to evaluate whether the treatment with plitidepsin, by attaining a reduction in the viral load and a faster recovery of the patient, could have a relevant impact on the emergence of sequelae resulting from the SARS-CoV-2 infection.
Interventions
DRUGPlitidepsin 1.5 mg / day
Plitidepsin 1.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 4.5 mg).
DRUGPlitidepsin 2.0 mg / day
Plitidepsin 2.0 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 6.0 mg).
DRUGPlitidepsin 2.5 mg / day
Plitidepsin 2.5 mg/day infused through a pump device over 1 hour and 30 minutes, 3 consecutive days (total dose 7.5 mg).
Sponsors
Apices Soluciones S.L.
PharmaMar
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Follow up Multicentric extension study of APLICOV-PC clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient who participated in the APLICOV-PC study receiving treatment with plitidepsin and who gives consent.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants With Complications Related to Post COVID-19 Infection | Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months. | Number and percentage of patients who developed complications related to post COVID-19 infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). | Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.. | Percentage of patients with complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). |
| Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2) | At study inclusion, an average of 12 months after end of APLICOV-PC study. | PaO2/FiO2 (Ratio of partial pressure arterial oxygen and fraction of inspired oxygen) mean, standard deviation. PaO2/FiO2 ratio to evaluate disease severity and discriminate between 'Moderate' and 'Severe' categories according to FDA guidance. |
| Forced Expiratory Volume 1 (FEV1) | At study inclusion, an average of 12 months after end of APLICOV-PC study. | FEV1 (Forced expiratory volume 1) mean, standard deviation. |
| Lung Diffusion Testing | At study inclusion, an average of 12 months after end of APLICOV-PC study. | Lung difussion testing: mean and standard deviation. Unit of measure: % reference theoretical value |
| Patients With Alterations in Chest Radiography | At study inclusion, an average of 12 months after end of APLICOV-PC study. | Percentage of patients with alterations in chest radiography |
| Patients With Electrocardiogram Alterations | At study inclusion, an average of 12 months after end of APLICOV-PC study. | Percentage of patients with electrocardiogram alterations |
| Patients With ≥Grade 2 Alterations in Laboratory Parameters | At study inclusion, an average of 12 months after end of APLICOV-PC study. | Percentage of patients with ≥grade 2 alterations in laboratory parameters Grade measured according to NCI-CTCAE v5.0 (National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0) where Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL\* Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
| Modified Medical Research Council (mMRC) Dyspnea Scale | At study inclusion, an average of 12 months after end of APLICOV-PC study. | Percentage of patients in each category of the Modified Medical Research Council (mMRC) dyspnea scale. The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1. shortness of breath when hurrying on the level or walking up a slight hill; 2. walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3. stops for breath after walking ∼100 m or after few minutes on the level; and 4. too breathless to leave the house, or breathless when dressing or undressing. |
| Patients Requiring Oxygen Therapy | Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months. | Percentage of patients requiring oxygen therapy |
| Forced Vital Capacity (FVC) | At study inclusion, an average of 12 months after end of APLICOV-PC study. | FVC mean, standard deviation. |
| Arterial Oxygen Saturation (SaO2) | At study inclusion, an average of 12 months after end of APLICOV-PC study. | SaO2 (Arterial oxygen saturation) mean, standard deviation. Unit of measure: percentage of oxygen saturation |
| Barthel Index | At study inclusion, an average of 12 months after end of APLICOV-PC study. | The Barthel index measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Percentage of patients at each category according to the score obtained: 0-20: Total dependence; 21-60: Severe dependence; 61-90: Moderate dependence; 91-99: Low dependence; 100: Independence |
| Patients Requiring Hospital Readmission | Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months. | Percentage of patients requiring hospital readmission |
| 6 Minute Walking Test (Total Distance) | At study inclusion, an average of 12 months after end of APLICOV-PC study. | minute walking test mean, standard deviation. Total distance measured in meters (m) |
| 6 Minute Walking Test (Expected Distance) | At study inclusion, an average of 12 months after end of APLICOV-PC study. | minute walking test mean, standard deviation. Expected distance (the predicted distance that a patient could walk) measured in meters (m) |
| 6 Minute Walking Test (Percentage of Predicted Distance) | At study inclusion, an average of 12 months after end of APLICOV-PC study. | 6 minute walking test mean, standard deviation. Unit of measure: Percentage of predicted distance |
| 6 Minute Walking Test (Number of Laps of 60 m) | At study inclusion, an average of 12 months after end of APLICOV-PC study. | 6 minute walking test mean, standard deviation. Unit of measure: Number of laps of 60 m |
| FEV1/FVC | At study inclusion, an average of 12 months after end of APLICOV-PC study. | FEV1/FVC mean, standard deviation. |
Countries
Spain
Participant flow
Recruitment details
Patients were included in the study between 25th January 2022 and 28th February 2022.
Pre-assignment details
All patients who participated in and received plitidepsin in the APLICOV-PC study are eligible candidates for participating in this extension study.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Experimental 1 1.5 mg of plitidepsin / day | 9 |
| Arm B: Experimental 2 2.0 mg of plitidepsin / day | 14 |
| Arm C: Experimental 3 2.5 mg of plitidepsin / day | 11 |
| Total | 34 |
Baseline characteristics
| Characteristic | Arm A: Experimental 1 | Arm B: Experimental 2 | Arm C: Experimental 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 53 years | 52.5 years | 54 years | 53 years |
| Body Surface Area | 1.9 m^2 | 2.0 m^2 | 1.9 m^2 | 1.9 m^2 |
| Height | 170.0 cm | 169.0 cm | 161.0 cm | 168.4 cm |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 7 Participants | 9 Participants | 7 Participants | 23 Participants |
| Race/Ethnicity, Customized Latin | 2 Participants | 3 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized North African | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 6 Participants | 23 Participants |
| Weight | 80.0 Kg | 88.5 Kg | 86.0 Kg | 84.8 Kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 14 | 0 / 11 |
| other Total, other adverse events | 0 / 9 | 0 / 14 | 0 / 11 |
| serious Total, serious adverse events | 0 / 9 | 0 / 14 | 0 / 11 |
Outcome results
Primary
Number and Percentage of Participants With Complications Related to Post COVID-19 Infection
Number and percentage of patients who developed complications related to post COVID-19 infection
Time frame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Experimental 1 | Number and Percentage of Participants With Complications Related to Post COVID-19 Infection | 4 Participants |
| Arm B: Experimental 2 | Number and Percentage of Participants With Complications Related to Post COVID-19 Infection | 8 Participants |
| Arm C: Experimental 3 | Number and Percentage of Participants With Complications Related to Post COVID-19 Infection | 5 Participants |
| Total | Number and Percentage of Participants With Complications Related to Post COVID-19 Infection | 17 Participants |
Secondary
6 Minute Walking Test (Expected Distance)
minute walking test mean, standard deviation. Expected distance (the predicted distance that a patient could walk) measured in meters (m)
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Experimental 1 | 6 Minute Walking Test (Expected Distance) | 806.7 m | Standard Deviation 101.7 |
| Arm B: Experimental 2 | 6 Minute Walking Test (Expected Distance) | 853.5 m | Standard Deviation 149.7 |
| Arm C: Experimental 3 | 6 Minute Walking Test (Expected Distance) | 818.7 m | Standard Deviation 101.9 |
| Total | 6 Minute Walking Test (Expected Distance) | 829.8 m | Standard Deviation 122.1 |
Secondary
6 Minute Walking Test (Number of Laps of 60 m)
6 minute walking test mean, standard deviation. Unit of measure: Number of laps of 60 m
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Experimental 1 | 6 Minute Walking Test (Number of Laps of 60 m) | 22.8 Number of laps of 60 m | Standard Deviation 14.7 |
| Arm B: Experimental 2 | 6 Minute Walking Test (Number of Laps of 60 m) | 14.0 Number of laps of 60 m | Standard Deviation 7.2 |
| Arm C: Experimental 3 | 6 Minute Walking Test (Number of Laps of 60 m) | 15.7 Number of laps of 60 m | Standard Deviation 12.5 |
| Total | 6 Minute Walking Test (Number of Laps of 60 m) | 16.9 Number of laps of 60 m | Standard Deviation 11.6 |
Secondary
6 Minute Walking Test (Percentage of Predicted Distance)
6 minute walking test mean, standard deviation. Unit of measure: Percentage of predicted distance
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Experimental 1 | 6 Minute Walking Test (Percentage of Predicted Distance) | 61.4 Percentage of predicted distance | Standard Deviation 16.8 |
| Arm B: Experimental 2 | 6 Minute Walking Test (Percentage of Predicted Distance) | 54.3 Percentage of predicted distance | Standard Deviation 11.9 |
| Arm C: Experimental 3 | 6 Minute Walking Test (Percentage of Predicted Distance) | 54.6 Percentage of predicted distance | Standard Deviation 16.6 |
| Total | 6 Minute Walking Test (Percentage of Predicted Distance) | 56.3 Percentage of predicted distance | Standard Deviation 14.8 |
Secondary
6 Minute Walking Test (Total Distance)
minute walking test mean, standard deviation. Total distance measured in meters (m)
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Experimental 1 | 6 Minute Walking Test (Total Distance) | 486.4 m | Standard Deviation 115.8 |
| Arm B: Experimental 2 | 6 Minute Walking Test (Total Distance) | 453.9 m | Standard Deviation 77.7 |
| Arm C: Experimental 3 | 6 Minute Walking Test (Total Distance) | 445.1 m | Standard Deviation 134 |
| Total | 6 Minute Walking Test (Total Distance) | 459.7 m | Standard Deviation 106.5 |
Secondary
Arterial Oxygen Saturation (SaO2)
SaO2 (Arterial oxygen saturation) mean, standard deviation. Unit of measure: percentage of oxygen saturation
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Experimental 1 | Arterial Oxygen Saturation (SaO2) | 97.2 Percentage of oxygen saturation | Standard Deviation 1.8 |
| Arm B: Experimental 2 | Arterial Oxygen Saturation (SaO2) | 97.1 Percentage of oxygen saturation | Standard Deviation 1.7 |
| Arm C: Experimental 3 | Arterial Oxygen Saturation (SaO2) | 98.1 Percentage of oxygen saturation | Standard Deviation 1.2 |
| Total | Arterial Oxygen Saturation (SaO2) | 97.4 Percentage of oxygen saturation | Standard Deviation 1.6 |
Secondary
Barthel Index
The Barthel index measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Percentage of patients at each category according to the score obtained: 0-20: Total dependence; 21-60: Severe dependence; 61-90: Moderate dependence; 91-99: Low dependence; 100: Independence
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Experimental 1 | Barthel Index | Obtained | 0 Participants |
| Arm A: Experimental 1 | Barthel Index | Total dependence | 0 Participants |
| Arm A: Experimental 1 | Barthel Index | Severe dependence | 0 Participants |
| Arm A: Experimental 1 | Barthel Index | Moderate dependence | 0 Participants |
| Arm A: Experimental 1 | Barthel Index | Low dependence | 0 Participants |
| Arm A: Experimental 1 | Barthel Index | Independence | 9 Participants |
| Arm B: Experimental 2 | Barthel Index | Independence | 14 Participants |
| Arm B: Experimental 2 | Barthel Index | Moderate dependence | 0 Participants |
| Arm B: Experimental 2 | Barthel Index | Obtained | 0 Participants |
| Arm B: Experimental 2 | Barthel Index | Severe dependence | 0 Participants |
| Arm B: Experimental 2 | Barthel Index | Total dependence | 0 Participants |
| Arm B: Experimental 2 | Barthel Index | Low dependence | 0 Participants |
| Arm C: Experimental 3 | Barthel Index | Total dependence | 0 Participants |
| Arm C: Experimental 3 | Barthel Index | Severe dependence | 0 Participants |
| Arm C: Experimental 3 | Barthel Index | Moderate dependence | 0 Participants |
| Arm C: Experimental 3 | Barthel Index | Independence | 11 Participants |
| Arm C: Experimental 3 | Barthel Index | Low dependence | 0 Participants |
| Arm C: Experimental 3 | Barthel Index | Obtained | 0 Participants |
| Total | Barthel Index | Low dependence | 0 Participants |
| Total | Barthel Index | Independence | 34 Participants |
| Total | Barthel Index | Total dependence | 0 Participants |
| Total | Barthel Index | Moderate dependence | 0 Participants |
| Total | Barthel Index | Obtained | 0 Participants |
| Total | Barthel Index | Severe dependence | 0 Participants |
Secondary
FEV1/FVC
FEV1/FVC mean, standard deviation.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Experimental 1 | FEV1/FVC | 79.9 Ratio | Standard Deviation 5.8 |
| Arm B: Experimental 2 | FEV1/FVC | 79.3 Ratio | Standard Deviation 8.6 |
| Arm C: Experimental 3 | FEV1/FVC | 78.1 Ratio | Standard Deviation 13 |
| Total | FEV1/FVC | 79.1 Ratio | Standard Deviation 9.4 |
Secondary
Forced Expiratory Volume 1 (FEV1)
FEV1 (Forced expiratory volume 1) mean, standard deviation.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Experimental 1 | Forced Expiratory Volume 1 (FEV1) | 3052 ml | Standard Deviation 865.4 |
| Arm B: Experimental 2 | Forced Expiratory Volume 1 (FEV1) | 3267 ml | Standard Deviation 774.9 |
| Arm C: Experimental 3 | Forced Expiratory Volume 1 (FEV1) | 2857 ml | Standard Deviation 1029 |
| Total | Forced Expiratory Volume 1 (FEV1) | 3078 ml | Standard Deviation 877.9 |
Secondary
Forced Vital Capacity (FVC)
FVC mean, standard deviation.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Experimental 1 | Forced Vital Capacity (FVC) | 3809 ml | Standard Deviation 1022 |
| Arm B: Experimental 2 | Forced Vital Capacity (FVC) | 4107 ml | Standard Deviation 827.2 |
| Arm C: Experimental 3 | Forced Vital Capacity (FVC) | 3751 ml | Standard Deviation 1222 |
| Total | Forced Vital Capacity (FVC) | 3913 ml | Standard Deviation 1001 |
Secondary
Lung Diffusion Testing
Lung difussion testing: mean and standard deviation. Unit of measure: % reference theoretical value
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Experimental 1 | Lung Diffusion Testing | 98.4 Percentage reference theoretical value | Standard Deviation 11.4 |
| Arm B: Experimental 2 | Lung Diffusion Testing | 100.1 Percentage reference theoretical value | Standard Deviation 24 |
| Arm C: Experimental 3 | Lung Diffusion Testing | 105.2 Percentage reference theoretical value | Standard Deviation 15.2 |
| Total | Lung Diffusion Testing | 101.3 Percentage reference theoretical value | Standard Deviation 18.4 |
Secondary
Modified Medical Research Council (mMRC) Dyspnea Scale
Percentage of patients in each category of the Modified Medical Research Council (mMRC) dyspnea scale. The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1. shortness of breath when hurrying on the level or walking up a slight hill; 2. walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3. stops for breath after walking ∼100 m or after few minutes on the level; and 4. too breathless to leave the house, or breathless when dressing or undressing.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Experimental 1 | Modified Medical Research Council (mMRC) Dyspnea Scale | 0 | 5 Participants |
| Arm A: Experimental 1 | Modified Medical Research Council (mMRC) Dyspnea Scale | 3 | 2 Participants |
| Arm A: Experimental 1 | Modified Medical Research Council (mMRC) Dyspnea Scale | 1 | 2 Participants |
| Arm A: Experimental 1 | Modified Medical Research Council (mMRC) Dyspnea Scale | 2 | 0 Participants |
| Arm B: Experimental 2 | Modified Medical Research Council (mMRC) Dyspnea Scale | 3 | 0 Participants |
| Arm B: Experimental 2 | Modified Medical Research Council (mMRC) Dyspnea Scale | 1 | 6 Participants |
| Arm B: Experimental 2 | Modified Medical Research Council (mMRC) Dyspnea Scale | 2 | 1 Participants |
| Arm B: Experimental 2 | Modified Medical Research Council (mMRC) Dyspnea Scale | 0 | 7 Participants |
| Arm C: Experimental 3 | Modified Medical Research Council (mMRC) Dyspnea Scale | 0 | 9 Participants |
| Arm C: Experimental 3 | Modified Medical Research Council (mMRC) Dyspnea Scale | 2 | 0 Participants |
| Arm C: Experimental 3 | Modified Medical Research Council (mMRC) Dyspnea Scale | 1 | 2 Participants |
| Arm C: Experimental 3 | Modified Medical Research Council (mMRC) Dyspnea Scale | 3 | 0 Participants |
| Total | Modified Medical Research Council (mMRC) Dyspnea Scale | 1 | 10 Participants |
| Total | Modified Medical Research Council (mMRC) Dyspnea Scale | 2 | 1 Participants |
| Total | Modified Medical Research Council (mMRC) Dyspnea Scale | 3 | 2 Participants |
| Total | Modified Medical Research Council (mMRC) Dyspnea Scale | 0 | 21 Participants |
Secondary
Patients Requiring Hospital Readmission
Percentage of patients requiring hospital readmission
Time frame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Experimental 1 | Patients Requiring Hospital Readmission | No readmission | 9 Participants |
| Arm A: Experimental 1 | Patients Requiring Hospital Readmission | No COVID-19 related | 0 Participants |
| Arm A: Experimental 1 | Patients Requiring Hospital Readmission | Post-COVID-19 complications | 0 Participants |
| Arm A: Experimental 1 | Patients Requiring Hospital Readmission | COVID-19 | 0 Participants |
| Arm B: Experimental 2 | Patients Requiring Hospital Readmission | Post-COVID-19 complications | 0 Participants |
| Arm B: Experimental 2 | Patients Requiring Hospital Readmission | No COVID-19 related | 1 Participants |
| Arm B: Experimental 2 | Patients Requiring Hospital Readmission | No readmission | 13 Participants |
| Arm B: Experimental 2 | Patients Requiring Hospital Readmission | COVID-19 | 0 Participants |
| Arm C: Experimental 3 | Patients Requiring Hospital Readmission | No COVID-19 related | 0 Participants |
| Arm C: Experimental 3 | Patients Requiring Hospital Readmission | COVID-19 | 0 Participants |
| Arm C: Experimental 3 | Patients Requiring Hospital Readmission | Post-COVID-19 complications | 0 Participants |
| Arm C: Experimental 3 | Patients Requiring Hospital Readmission | No readmission | 11 Participants |
| Total | Patients Requiring Hospital Readmission | Post-COVID-19 complications | 0 Participants |
| Total | Patients Requiring Hospital Readmission | COVID-19 | 0 Participants |
| Total | Patients Requiring Hospital Readmission | No readmission | 33 Participants |
| Total | Patients Requiring Hospital Readmission | No COVID-19 related | 1 Participants |
Secondary
Patients Requiring Oxygen Therapy
Percentage of patients requiring oxygen therapy
Time frame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Experimental 1 | Patients Requiring Oxygen Therapy | 1 Participants |
| Arm B: Experimental 2 | Patients Requiring Oxygen Therapy | 2 Participants |
| Arm C: Experimental 3 | Patients Requiring Oxygen Therapy | 0 Participants |
| Total | Patients Requiring Oxygen Therapy | 3 Participants |
Secondary
Patients With Alterations in Chest Radiography
Percentage of patients with alterations in chest radiography
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Experimental 1 | Patients With Alterations in Chest Radiography | 0 Participants |
| Arm B: Experimental 2 | Patients With Alterations in Chest Radiography | 0 Participants |
| Arm C: Experimental 3 | Patients With Alterations in Chest Radiography | 0 Participants |
| Total | Patients With Alterations in Chest Radiography | 0 Participants |
Secondary
Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not).
Percentage of patients with complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not).
Time frame: Since last visit of APLICOV-PC study until the end of this extension study, an average of 12 months..
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Experimental 1 | Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). | Without complications | 1 Participants |
| Arm A: Experimental 1 | Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). | Regardless relationship, i.e. related to COVID-19 infection or not. | 8 Participants |
| Arm B: Experimental 2 | Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). | Regardless relationship, i.e. related to COVID-19 infection or not. | 12 Participants |
| Arm B: Experimental 2 | Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). | Without complications | 2 Participants |
| Arm C: Experimental 3 | Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). | Without complications | 5 Participants |
| Arm C: Experimental 3 | Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). | Regardless relationship, i.e. related to COVID-19 infection or not. | 6 Participants |
| Total | Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). | Without complications | 8 Participants |
| Total | Patients With Complications Post COVID-19 Infection (Regardless Relationship, i.e. Related to COVID-19 Infection or Not). | Regardless relationship, i.e. related to COVID-19 infection or not. | 26 Participants |
Secondary
Patients With Electrocardiogram Alterations
Percentage of patients with electrocardiogram alterations
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Experimental 1 | Patients With Electrocardiogram Alterations | 1 Participants |
| Arm B: Experimental 2 | Patients With Electrocardiogram Alterations | 3 Participants |
| Arm C: Experimental 3 | Patients With Electrocardiogram Alterations | 1 Participants |
| Total | Patients With Electrocardiogram Alterations | 5 Participants |
Secondary
Patients With ≥Grade 2 Alterations in Laboratory Parameters
Percentage of patients with ≥grade 2 alterations in laboratory parameters Grade measured according to NCI-CTCAE v5.0 (National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0) where Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL\* Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Experimental 1 | Patients With ≥Grade 2 Alterations in Laboratory Parameters | 1 Participants |
| Arm B: Experimental 2 | Patients With ≥Grade 2 Alterations in Laboratory Parameters | 1 Participants |
| Arm C: Experimental 3 | Patients With ≥Grade 2 Alterations in Laboratory Parameters | 1 Participants |
| Total | Patients With ≥Grade 2 Alterations in Laboratory Parameters | 3 Participants |
Secondary
Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2)
PaO2/FiO2 (Ratio of partial pressure arterial oxygen and fraction of inspired oxygen) mean, standard deviation. PaO2/FiO2 ratio to evaluate disease severity and discriminate between 'Moderate' and 'Severe' categories according to FDA guidance.
Time frame: At study inclusion, an average of 12 months after end of APLICOV-PC study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Experimental 1 | Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2) | 472.0 Ratio | Standard Deviation 85.9 |
| Arm B: Experimental 2 | Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2) | 464.2 Ratio | Standard Deviation 90.3 |
| Arm C: Experimental 3 | Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2) | 518.7 Ratio | Standard Deviation 99.1 |
| Total | Ratio of Partial Pressure Arterial Oxygen (PaO2) and Fraction of Inspired Oxygen (FiO2) | 482.8 Ratio | Standard Deviation 92.2 |